Feeding tube kit recalled due to blocked connector preventing guidewire advancement
Boston Scientific's EndoVive 20Fr PEG kit may have a blocked connector preventing proper guidewire advancement during placement, potentially requiring emergency intervention.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a risk-of-harm product where the manufacturing defect could cause serious complications including bleeding, gastric leakage, and aspiration. No illnesses or injuries have been reported.
Plain-English summary
Boston Scientific Corporation is recalling 2,501 units of the EndoVive 20Fr Push Safety PEG Kit due to a manufacturing defect. The feeding tube kit is intended for patients who cannot eat normally and delivers nutrition directly into the stomach.
During placement, the guidewire may be unable to advance through the feeding tube because the barb connector has a blocked lumen. When advancement is blocked, the placement procedure must be prolonged or the device must be removed and replaced. This can lead to additional medical interventions, including further incisions to close puncture sites, bleeding, leakage of gastric contents into the peritoneal cavity, and aspiration.
Healthcare providers and patients who may have received affected units should contact Boston Scientific immediately for recall instructions. The recall affects units distributed nationwide in the United States and in Japan.
The recalled product
- Product
- EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00566471
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Feeding Tube
- Affected units
- 2,501
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN: 08714729802631 Lot Numbers: 32295181
- 32295182
- 32306054
- 32306055
- 32316800
- 32323673
- 32342013
- 32367049
- 32367050
- 32374782
- 32472868
- 32486230
- 32486231
- 32486232
- 32486233
- 32506056
- 32515039
- 32523243
- 32523244
- 32531793
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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